ZIMMER AIR DERMATOME

Additional Manufacturer Narrative

AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. G2: FOREIGN - EVENT OCCURRED IN CANADA.

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY, THE UNIT SKIPPED WHEN IT CAME INTO CONTACT WITH THE SKIN, CAUSING A SMALL SUPERFICIAL GOUGE ON THE PATIENT. THE HARVESTED GRAFT WAS DAMAGED, AND AN ADDITIONAL UNPLANNED GRAFT WAS TAKEN. THERE WAS PATIENT IMPACT, AND A SMALL DELAY OCCURRED DUE TO THE PREPARATION OF A BACKUP PRODUCT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.